Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
4 other identifiers
interventional
274
1 country
118
Brief Summary
This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2025
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedStudy Start
First participant enrolled
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
March 31, 2026
December 1, 2025
2.5 years
January 29, 2025
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative pancreatic fistula (POPF)
POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.
Up to 60 days after distal pancreatectomy
Secondary Outcomes (3)
Incidence of biochemical leak (BL)
Up to 60 days after distal pancreatectomy
Number of post-operation hospital days
From the time of surgery up to 60 days after distal pancreatectomy
Change in overall quality of life (QOL)
At baseline and at 14 and 60 days after surgery
Other Outcomes (6)
Changes in pancreatic specific QOL
At baseline and up to 60 days after distal pancreatectomy
Change in health-related QOL
At baseline and up to 60 days after distal pancreatectomy
Delayed gastric emptying (DGE)
Up to 60 days after distal pancreatectomy
- +3 more other outcomes
Study Arms (2)
Arm I (lanreotide, distal pancreatectomy)
EXPERIMENTALPatients receive lanreotide SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
Arm II (saline placebo, distal pancreatectomy)
PLACEBO COMPARATORPatients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
Interventions
Undergo blood sample and pancreas fluid collection
Undergo distal pancreatectomy
Given SC
Ancillary studies
Given SC
Eligibility Criteria
You may qualify if:
- Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
- Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date
- Participants must not have a known history of a prior diagnosis of malabsorption syndrome
- Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization
- Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization
- Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization
- Participants must be ≥ 18 years old
- Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization
- Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to registration/randomization
- Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:
- Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed
- Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels
- Bromocriptine: Dose adjustments may be considered to account for absorption changes
- Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary
- CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (118)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, 36526, United States
Thomas Hospital
Fairhope, Alabama, 36532, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, 36571, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
Moffitt Cancer Center at SouthShore
Ruskin, Florida, 33570, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Riverwood Healthcare Center
Aitkin, Minnesota, 56431, United States
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, 56442, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Essentia Health - Ely Clinic
Ely, Minnesota, 55731, United States
Essentia Health - Fosston
Fosston, Minnesota, 56542, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649, United States
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota, 55767, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
Essentia Health - Saint Joseph's Pequot Lakes Clinic
Pequot Lakes, Minnesota, 56472, United States
Essentia Health - Saint Joseph's Pine River Clinic
Pine River, Minnesota, 56474, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Essentia Health - Saint Joseph's Staples Clinic
Staples, Minnesota, 56479, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, 18104, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045, United States
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, 18951, United States
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, 18360, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033, United States
Valley Health / Winchester Medical Center
Winchester, Virginia, 22601, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843, United States
Tamarack Health Hayward Medical Center
Hayward, Wisconsin, 54843, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan G Sham
SWOG Cancer Research Network
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Participant, surgeon, and the clinical care team are blinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2025
First Posted
February 4, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
March 31, 2026
Record last verified: 2025-12